CN111467311A - Doxycycline hydrochloride soluble powder and preparation method thereof - Google Patents
Doxycycline hydrochloride soluble powder and preparation method thereof Download PDFInfo
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- CN111467311A CN111467311A CN202010414714.2A CN202010414714A CN111467311A CN 111467311 A CN111467311 A CN 111467311A CN 202010414714 A CN202010414714 A CN 202010414714A CN 111467311 A CN111467311 A CN 111467311A
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- doxycycline hydrochloride
- soluble powder
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- hydrochloride soluble
- doxycycline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/65—Tetracyclines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Abstract
The invention relates to the field of veterinary drug preparations, and particularly discloses doxycycline hydrochloride soluble powder and a preparation method thereof, aiming at solving the technical problems of poor solubility and low bioavailability of the existing doxycycline hydrochloride soluble powder. The doxycycline hydrochloride soluble powder comprises the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 5-20% of anhydrous citric acid, 4-10% of disodium ethylenediamine tetraacetic acid and 60-81% of anhydrous glucose. The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps of (1) weighing all raw materials according to mass fraction; (2) pulverizing the raw materials, and mixing for 10-40 min; (3) and (3) subpackaging the raw materials obtained in the step (2) to obtain the compound feed. Compared with the traditional doxycycline hydrochloride soluble powder, the doxycycline hydrochloride soluble powder has the advantages of higher solubility, better stability, higher bioavailability, scientific formula, simple preparation method and low cost.
Description
Technical Field
The invention relates to the field of veterinary drug preparations, and particularly relates to doxycycline hydrochloride soluble powder and a preparation method thereof.
Background
The doxycycline hydrochloride is a doxycycline broad-spectrum antibiotic, has antibacterial activity higher than that of oxytetracycline and tetracycline, and is mainly used for treating mycoplasmosis, colibacillosis, salmonellosis, pasteurellosis, psittacosis and the like of livestock and poultry. The doxycycline hydrochloride soluble powder has the advantages of convenient administration, quick absorption after oral administration, strong tissue permeability, long effective blood concentration maintenance time and the like, and is widely applied in veterinary clinic.
But the doxycycline hydrochloride contains unstable groups such as phenolic hydroxyl and the like, so that oxidation and hydrolysis are easy to occur, and the drug fails too fast. In the breeding production process, doxycycline hydrochloride easily generates a chelation reaction with metal ions in water or food, the drug effect is easily reduced, and chelate is deposited in the wall of a water fountain or a drinking water line, so that the water line is blocked, and the clinical use is seriously influenced. The traditional doxycycline hydrochloride soluble powder is prepared by mixing doxycycline hydrochloride and glucose, and the problems of easy degradation and easy chelation in the practical application process cannot be solved, so that the drug effect is reduced and the bioavailability is low.
In conclusion, it is necessary to research a doxycycline hydrochloride soluble powder with better solubility, higher stability and longer drug effect.
Disclosure of Invention
The first purpose of the invention is doxycycline hydrochloride soluble powder with better solubility, higher stability and more durable drug effect.
In order to realize the first purpose of the invention, the invention provides the technical scheme that:
the doxycycline hydrochloride soluble powder comprises the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 5-20% of anhydrous citric acid, 4-10% of disodium ethylenediamine tetraacetic acid and 60-81% of anhydrous glucose.
Further, the doxycycline hydrochloride soluble powder consists of the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 10-15% of anhydrous citric acid, 5-10% of disodium ethylenediamine tetraacetic acid and 65-75% of anhydrous glucose.
Further, the doxycycline hydrochloride soluble powder consists of the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 10% of anhydrous citric acid, 5% of disodium ethylene diamine tetraacetate and 75% of anhydrous glucose.
The second purpose of the invention is to provide a preparation method of doxycycline hydrochloride soluble powder, which has simple processing technology and low production cost.
In order to achieve the second object of the invention, the technical scheme provided by the invention is as follows:
a preparation method of doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials according to the mass fraction;
(2) pulverizing the raw materials, and mixing for 10-40 min;
(3) and (3) subpackaging the raw materials obtained in the step (2) to obtain the compound feed.
Further, in the step (2), the raw materials are crushed to 65-100 meshes.
Compared with the prior art, the invention has the beneficial effects that:
1. in the doxycycline hydrochloride soluble powder provided by the invention, anhydrous citric acid as a raw material is an acidifier, and mainly plays a role in reducing the pH value and increasing the stability of doxycycline hydrochloride; disodium edetate is a chelating agent that protects doxycycline hyclate from chelating metal ions, increasing its solubility.
2. The doxycycline hydrochloride soluble powder provided by the invention has better solubility, higher stability and longer drug effect.
3. The preparation method of the doxycycline hydrochloride soluble powder provided by the invention has the advantages of simple production process and low cost, and the prepared doxycycline hydrochloride soluble powder is more suitable for drinking water administration, is convenient for clinical application and is easy to realize large-scale production.
Drawings
The technical solutions of the present invention are further described in detail with reference to the specific embodiments in the drawings, but the present invention is not limited thereto.
Figure 1 is a graph comparing the solubility of doxycycline hydrochloride soluble powder to ordinary doxycycline hydrochloride soluble powder of example 1 of the present invention;
figure 2 is a graph comparing the appearance of doxycycline hyclate soluble powder to that of ordinary doxycycline hyclate soluble powder of example 2 of the present invention.
Detailed Description
The technical solution of the present invention will be described in further detail with reference to the following embodiments, but the present invention is not limited thereto.
Example 1
10% of doxycycline hydrochloride, 10% of anhydrous citric acid, 5% of disodium ethylene diamine tetraacetate and 75% of anhydrous glucose.
The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials of each component according to the mass percentage;
(2) respectively crushing and sieving raw materials of doxycycline hydrochloride, anhydrous citric acid, disodium ethylene diamine tetraacetate and anhydrous glucose, wherein the mesh number of a screen is 100 meshes;
(3) uniformly mixing the materials obtained in the step (2) for 20 min; subpackaging and inspecting to obtain the doxycycline hydrochloride soluble powder finished product.
Example 2
10% of doxycycline hydrochloride, 8% of anhydrous citric acid, 8% of disodium ethylene diamine tetraacetate and 74% of anhydrous glucose.
The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials of each component according to the mass percentage;
(2) respectively crushing and sieving raw materials of doxycycline hydrochloride, anhydrous citric acid, disodium ethylene diamine tetraacetate and anhydrous glucose, wherein the mesh number of a screen is 80 meshes;
(3) uniformly mixing the materials obtained in the step (2) for 20 min; subpackaging and inspecting to obtain the doxycycline hydrochloride soluble powder finished product.
Example 3
10% of doxycycline hydrochloride, 12% of anhydrous citric acid, 6% of disodium ethylenediamine tetraacetate and 72% of anhydrous glucose.
The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials of each component according to the mass percentage;
(2) respectively crushing and sieving raw materials of doxycycline hydrochloride, anhydrous citric acid, disodium ethylene diamine tetraacetate and anhydrous glucose, wherein the mesh number of a screen is 65 meshes;
(3) uniformly mixing the materials obtained in the step (2) for 10 min; subpackaging and inspecting to obtain the doxycycline hydrochloride soluble powder finished product.
Example 4
10% of doxycycline hydrochloride, 20% of anhydrous citric acid, 5% of disodium ethylenediamine tetraacetate and 65% of anhydrous glucose.
The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials of each component according to the mass percentage;
(2) respectively crushing and sieving raw materials of doxycycline hydrochloride, anhydrous citric acid, disodium ethylene diamine tetraacetate and anhydrous glucose, wherein the mesh number of a screen is 80 meshes;
(3) uniformly mixing the materials obtained in the step (2) for 15 min; subpackaging and inspecting to obtain the doxycycline hydrochloride soluble powder finished product.
Example 5
10% of doxycycline hydrochloride, 15% of anhydrous citric acid, 10% of disodium ethylenediamine tetraacetate and 65% of anhydrous glucose.
The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials of each component according to the mass percentage;
(2) respectively crushing and sieving raw materials of doxycycline hydrochloride, anhydrous citric acid, disodium ethylene diamine tetraacetate and anhydrous glucose, wherein the mesh number of a screen is 100 meshes;
(3) uniformly mixing the materials obtained in the step (2) for 25 min; subpackaging and inspecting to obtain the doxycycline hydrochloride soluble powder finished product.
Example 6
10% of doxycycline hydrochloride, 12% of anhydrous citric acid, 8% of disodium ethylene diamine tetraacetate and 70% of anhydrous glucose.
The preparation method of the doxycycline hydrochloride soluble powder comprises the following steps:
(1) weighing the raw materials of each component according to the mass percentage;
(2) respectively crushing and sieving raw materials of doxycycline hydrochloride, anhydrous citric acid, disodium ethylene diamine tetraacetate and anhydrous glucose, wherein the mesh number of a screen is 65 meshes;
(3) uniformly mixing the materials obtained in the step (2) for 15 min; subpackaging and inspecting to obtain the doxycycline hydrochloride soluble powder finished product.
In order to further verify the technical effect of the doxycycline hydrochloride soluble powder finished product, the following experiments are carried out:
1. comparative solubility test
The doxycycline hydrochloride soluble powder prepared in example 1 and ordinary doxycycline hydrochloride soluble powder (namely doxycycline hydrochloride soluble powder product formed by mixing doxycycline hydrochloride and glucose) are taken to be respectively subjected to solubility tests, namely 2.0g of the doxycycline hydrochloride soluble powder product obtained in example 1 and the ordinary doxycycline hydrochloride soluble powder are respectively dissolved in 100m L of well water and are uniformly stirred to obtain a solubility comparison graph shown in figure 1, wherein the left side is a picture of the ordinary doxycycline hydrochloride soluble powder after being dissolved, and the right side is a picture of the doxycycline hydrochloride soluble powder product of example 1.
2. Appearance contrast
The doxycycline hydrochloride soluble powder product prepared in the example 2 and the common doxycycline hydrochloride soluble powder are respectively placed at room temperature for observation, and the color, the shape and the mixing are compared for observation to determine whether the mixture is uniform. Figure 2 is a comparison graph of the appearance of doxycycline hyclate soluble powder prepared in example 2 of the present invention and that of ordinary doxycycline hyclate soluble powder. In the figure, A is the soluble powder of ordinary doxycycline hydrochloride, and B is the soluble powder of doxycycline hydrochloride prepared in example 2. As can be seen from the figure, the common doxycycline hydrochloride soluble powder is a powder particle mixture between yellow and white, while the doxycycline hydrochloride soluble powder of the present invention is a yellowish uniform powder, which indicates that the doxycycline hydrochloride soluble powder of the present invention has better mixing uniformity.
3. Experiment of content stability
The doxycycline hydrochloride soluble powder products prepared in examples 1 to 6 and the ordinary doxycycline hydrochloride soluble powder were dissolved in well water, respectively, and then an effective content stability test was performed within 4 hours, with the results shown in table 1.
TABLE 1 content stability COMPARATIVE TABLE
As can be seen from the data in table 1, the effective components of the ordinary doxycycline hydrochloride soluble powder are rapidly reduced with the time being prolonged, which is caused by the fact that the doxycycline hydrochloride chelates metal ions in water and oxidation reaction occurs, and the content of the doxycycline hydrochloride soluble powder prepared in the embodiments 1 to 6 of the present invention is basically stable within 4 hours, which indicates that the doxycycline hydrochloride soluble powder prepared in the present invention is more stable and more suitable for practical clinical application.
4. Clinical application experiment
Experimental animals:
210 broilers with uniform weight and respiratory diseases at the age of 20 days are selected. The clinical symptoms are manifested by listlessness, decreased feed intake, asthma, cough, sinus swelling, nasal discharge, and reluctant to walk. It was randomly divided into 7 groups of 30 pieces.
Grouping administration:
(1) the group 1 is the doxycycline hydrochloride soluble powder group prepared in the example 1, each 3.0g of doxycycline hydrochloride soluble powder group is added with 1L of water for drinking, and the water is freely drunk after drinking for three days continuously;
(2) the group 2 is the doxycycline hydrochloride soluble powder group prepared in the example 2, each 3.0g of doxycycline hydrochloride soluble powder group is added with 1L of water for drinking, and the water is freely drunk after drinking for three days continuously;
(3) the 3 rd group is the doxycycline hydrochloride soluble powder group prepared in the example 3, each 3.0g of doxycycline hydrochloride soluble powder group is added with 1L of water for drinking, and the water is freely drunk after drinking for three days continuously;
(4) the 4 th group is the doxycycline hydrochloride soluble powder group prepared in the example 4, each 3.0g of doxycycline hydrochloride soluble powder group is added with 1L of water for drinking, and the water is freely drunk after drinking for three days continuously;
(5) the 5 th group is the doxycycline hydrochloride soluble powder group prepared in the example 5, each 3.0g of doxycycline hydrochloride soluble powder group is added with 1L of water for drinking, and the water is freely drunk after drinking for three days continuously;
(6) the 6 th group is the doxycycline hydrochloride soluble powder group prepared in the example 6, each 3.0g of doxycycline hydrochloride soluble powder group is added with 1L of water for drinking, and water is freely drunk after drinking for three days continuously;
(7) the 7 th group is administered with common doxycycline hydrochloride soluble powder (composed of 10% doxycycline hydrochloride and 90% anhydrous glucose), and is administered with 1L water per 3.0g, and after drinking, the water is freely drunk for three days.
Evaluation index of drug efficacy:
the following indexes are obtained by data acquisition and calculation after the medicine is taken for one week.
(1) Number of deaths: refers to the number of chickens with increased respiratory symptoms and died during the course of the experiment.
(2) Effective number: after the medicine is taken, the respiratory tract symptoms are reduced or disappeared, and the mental state and the feed intake are improved or recovered to be normal.
(3) The cure rate is as follows: after the medicine is taken, respiratory symptoms disappear, and the mental state and the feed intake are recovered to be normal.
(3) The cure rate is as follows: the number of cures accounted for several percent of the group of chickens.
(4) Average daily gain: means the average of the total weight gain of the surviving chickens in each group at the end of the experiment.
TABLE 2 treatment effect and weight gain of the drugs on respiratory diseases of broilers
| Group of | Number of experimental chickens | Number of deaths | Effective number | Number of cure | Cure rate | Average daily gain |
| 1 | 30 | 0 | 30 | 30 | 100 | 72.4 |
| 2 | 30 | 0 | 29 | 28 | 93 | 70.8 |
| 3 | 30 | 0 | 28 | 28 | 93 | 71.7 |
| 4 | 30 | 1 | 28 | 27 | 90 | 71.2 |
| 5 | 30 | 0 | 30 | 27 | 90 | 70.3 |
| 6 | 30 | 0 | 30 | 29 | 96.7 | 70.5 |
| 7 | 30 | 6 | 20 | 16 | 53.3 | 61.8 |
The data show that the doxycycline hydrochloride soluble powder prepared in the embodiments 1 to 6 has a cure rate of over 90 percent on respiratory diseases of broiler chickens, and the average daily weight gain is over 70.3g, which is obviously superior to the treatment effect of the common doxycycline hydrochloride soluble powder (consisting of 10 percent of doxycycline hydrochloride and 90 percent of anhydrous glucose), and the treatment effect of the doxycycline hydrochloride soluble powder provided by the invention is better.
The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.
Claims (5)
1. The doxycycline hydrochloride soluble powder is characterized by comprising the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 5-20% of anhydrous citric acid, 4-10% of disodium ethylenediamine tetraacetic acid and 60-81% of anhydrous glucose.
2. The doxycycline hydrochloride soluble powder according to claim 1, which is prepared from the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 10-15% of anhydrous citric acid, 5-10% of disodium ethylenediamine tetraacetic acid and 65-75% of anhydrous glucose.
3. The doxycycline hydrochloride soluble powder according to claim 1 or 2, which is prepared from the following raw materials in percentage by mass: 10% of doxycycline hydrochloride, 10% of anhydrous citric acid, 5% of disodium ethylene diamine tetraacetate and 75% of anhydrous glucose.
4. The preparation method of doxycycline hydrochloride soluble powder, which is claimed in claim 1, is characterized by comprising the following steps:
(1) weighing the raw materials according to the mass fraction;
(2) pulverizing the raw materials, and mixing for 10-40 min;
(3) and (3) subpackaging the raw materials obtained in the step (2) to obtain the compound feed.
5. The preparation method of doxycycline hydrochloride soluble powder according to claim 4, wherein in the step (2), the raw materials are crushed to 65-100 meshes.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010414714.2A CN111467311A (en) | 2020-05-15 | 2020-05-15 | Doxycycline hydrochloride soluble powder and preparation method thereof |
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| CN202010414714.2A CN111467311A (en) | 2020-05-15 | 2020-05-15 | Doxycycline hydrochloride soluble powder and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115487154A (en) * | 2022-11-17 | 2022-12-20 | 山东国邦药业有限公司 | Preparation method of doxycycline hydrochloride granules |
| CN117731644A (en) * | 2024-02-21 | 2024-03-22 | 中国农业科学院农业环境与可持续发展研究所 | Doxycycline hydrochloride nano controlled release agent for livestock and preparation method thereof |
| CN117731644B (en) * | 2024-02-21 | 2024-05-03 | 中国农业科学院农业环境与可持续发展研究所 | Doxycycline hydrochloride nano controlled release agent for livestock and preparation method thereof |
-
2020
- 2020-05-15 CN CN202010414714.2A patent/CN111467311A/en not_active Withdrawn
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115487154A (en) * | 2022-11-17 | 2022-12-20 | 山东国邦药业有限公司 | Preparation method of doxycycline hydrochloride granules |
| CN115487154B (en) * | 2022-11-17 | 2023-02-21 | 山东国邦药业有限公司 | Preparation method of doxycycline hydrochloride granules |
| CN117731644A (en) * | 2024-02-21 | 2024-03-22 | 中国农业科学院农业环境与可持续发展研究所 | Doxycycline hydrochloride nano controlled release agent for livestock and preparation method thereof |
| CN117731644B (en) * | 2024-02-21 | 2024-05-03 | 中国农业科学院农业环境与可持续发展研究所 | Doxycycline hydrochloride nano controlled release agent for livestock and preparation method thereof |
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Application publication date: 20200731 |